We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Donepezil Versus Non-drug Treatment in Alzheimer's Disease. (CHOLINE-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04661280
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : February 23, 2023
Sponsor:
Collaborator:
France Alzheimer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Donepezil, as well as the other symptomatic drugs of Alzheimer's disease, is not any more reimbursed by the French healthcare system, due to a controversy about its efficiency. French health authorities currently preconize a non-rug approach based on cognitive remediation or stimulation.

The aim of this study is to compare the efficiency of the 2 approaches (non-drug versus donepezil) on the symptoms of Alzheimer's disease after 6 months of treatment.


Condition or disease Intervention/treatment Phase
Alzheimer Disease, Early Onset Drug: Donepezil Phase 3

Detailed Description:

Randomized multicentric open-label study, comparison of 2 therapeutic strategies.

2 arms:

  • Standard of care, non-drug approach: following the recommendations of the Alzheimer's disease care by the Frenchh Health Authority. The care is cognitive, psychic, functional or social and centered on the patient and his environment. This care is best carried out by the memory consultations participating in this study and having extensive experience in the care of Alzheimer patients. It is usually based in particular on the prescription of cognitive stimulation sessions by a speech therapist and a mobile Alzheimer specialist team at home for cognitive remediation sessions.
  • Donepezil group: Management similar to the previous arm plus addition of Donepezil 5 mg per os once a day for one month and then 10 mg per os once a day until the 6th month.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multicentric, Randomized, Open Study : the CHOLINE-2 Study
Actual Study Start Date : February 10, 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Cognitive remediation
Non-drug treatment, cognitive remediation, cognitive stimulation
Experimental: Cognitive remediation + Donepezil
Non-drug treatment, cognitive remediation, cognitive stimulation + Donepezil
 Drug: Donepezil
Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.
Other Name: Aricept


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Difference of change in the MMSE score [ Time Frame: 26 weeks ]
    Difference of change in the MMSE score between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). MMSE is measured at baseline, 6 weeks, 13 weeks, and 26 weeks.


Secondary Outcome Measures :
  1. Difference of change in the ADAS-Cog scale [ Time Frame: 26 weeks ]

    Difference of change in the ADAS-Cog scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).

    ADAS-Cog scale = Alzheimer's Disease Assessment Scale-Cognitive Subscale, scored from 0 to 70


  2. Difference of change in the CDR scale [ Time Frame: 26 weeks ]

    Difference of change in the CDR scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).

    CDR scale = Clinical Dementia Rating, scored from 0 to 3


  3. Difference of change in the ADL scale [ Time Frame: 26 weeks ]

    Difference of change in the ADL scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).

    ADL scale = Autonomy scale on daily activities, scored from 0 to 78


  4. Difference of change in the quality of life scale [ Time Frame: 26 weeks ]
    Difference of change in the quality of life scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).

  5. Difference of change in the ZARIT scale [ Time Frame: 26 weeks ]

    Difference of change in the ZARIT scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).

    ZARIT scale = for assessing caregiver burden, scored from 0 to 88



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's disease according to the IWG-2 criteria.
  • Age ≥ 50 years.
  • Absence of legal protection measures (guardianship, curatorship).
  • MMSE score ≥ 10 at inclusion.
  • abnormal values for Aβ42 in the CSF or Aβ40 / Aβ42 ratio.
  • abnormal values for phosphorylated Tau in CSF
  • Presence of a family carer or a person at home who can ensure compliance with treatment if MMSE score <20.
  • French native speaker.

Exclusion Criteria:

  • Other cause of dementia.
  • Previous use of symptomatic treatment for Alzheimer's disease.
  • Hypersensitivity to donepezil hydrochloride or to any of the excipients listed in the SPC.
  • Cardiological contraindication after possible opinion of a cardiologist, at the initiative of the investigator, in particular bradycardia, sinus disease or other supra-ventricular conduction abnormalities such as sinoatrial or atrioventricular block.
  • Patients at particular risk of ulcer, known ulcer disease or receiving concomitant treatment with non-steroidal anti-inflammatory drugs.
  • Patient at risk of urinary retention.
  • History of epileptic disease.
  • History of neuroleptic malignant syndrome.
  • History of asthma or obstructive bronchopulmonary disease.
  • Severe hepatic impairment.

  • Taking one of the following treatments:

    • CYP3A4 inhibitors, such as ketonazole.
    • 2D6 inhibitors, such as quinidine.
    • CYP3A4 inhibitors, such as itraconazole and erythromycin.
    • CYP2D6 inhibitors, such as fluoxetine.
    • Enzyme inducers such as rifampicin, phenytoin, carbamazepine.
  • Participation in another interventional study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661280


Contacts
Layout table for location contacts
Contact: DUMURGIER Julien, MD, PhD +33140054313 julien.dumurgier@aphp.fr
Contact: PAQUET Claire, MD, PhD claire.paquet@inserm.fr

Locations
Layout table for location information
France
Cognitive Neurology Center Recruiting
Paris, France, 75010
Contact: DUMURGIER Julien, MD, PhD    +33140054313    julien.dumurgier@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
France Alzheimer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04661280    
Other Study ID Numbers: APHP201183
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alzheimer Disease
Donepezil
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents